Anchored brachytherapy device

ABSTRACT

Aspects herein are directed to an anchorable brachytherapy device configured to be permanently implanted in a tumor bed at the time of operative removal of the tumor. In exemplary aspects, the brachytherapy device may comprise a plurality of hollow tubes that form a spherical or ellipsoid shape. Protrusions or grooves may be formed on an outer surface of the tubes to help anchor the brachytherapy device in the tumor bed. Radioactive seeds or strands may be positioned within the tube channels to provide radiation to the tumor bed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application having attorney docket number ABDA.280038a and entitled“Anchored Brachytherapy Device,” claims the benefit of priority of U.S.Prov. App. No. 62/585,303, entitled “Anchored Brachytherapy Device,” andfiled Nov. 13, 2017. The entirety of the aforementioned application isincorporated by reference herein.

TECHNICAL FIELD

Aspects herein relate to an anchored, permanently implantablebrachytherapy device.

BACKGROUND

Radiation therapy, or brachytherapy, is a known modality for treatingcertain types of tumors such as, for example, breast tumors, braintumors, lung tumors, sarcomas, and the like and has been shown to resultin good tumor control. Brachytherapy may be used by itself or incombination with other therapies such as surgical resection, and/orchemotherapy. Radiation therapy has traditionally been administeredusing external beam radiation and/or by temporarily delivering aradioactive source to a tumor site via, for example a catheter. Both ofthese treatment modalities take days to weeks to complete and can beexpensive, inconvenient to the patient, time-consuming to the patientand the treatment staff, and potentially painful to the patient. Forexample, catheter-based partial breast radiation may take five to eightdays, and the patient has to be treated twice a day, six hours apart,and the catheter stays in the patient for two to three weeks. Duringthis time, the catheter tail protrudes outside of the patient causingpain and a possible infection risk. Moreover, catheter-based radiationrequires planning prior to each treatment which is time-consuming andexpensive. Because of this, some patients may opt for more radical, butsometimes unnecessary, treatment options such as, for example,mastectomy instead of lumpectomy and adjuvant radiation with respect tobreast cancer.

SUMMARY OF INVENTION

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. The present invention is defined by the claims.

Aspects herein are directed to an implantable and anchorablebrachytherapy device. Aspects herein may also be directed to animplantable and anchorable stereotactic marker device. With respect tothe implantable and anchorable brachytherapy device, aspects hereincontemplate a bioabsorbable or biocompatible, three-dimensional (3-D) ortwo-dimensional (2-D) device that can be, for instance, permanentlyintroduced into a tumor bed at the time of surgical resection of thetumor and which does not need to be removed. As such, the brachytherapydevices described herein provide a convenient and cost-effectivealternative to traditional catheter-based and/or external beam radiationoptions. Moreover, because the device is enclosed within the tumor bed,there are no catheter tails protruding from the patient, which lowersthe risk of pain, bleeding, and infection. Further, because the deviceis anchored within the tumor bed, the risk of device rotation and/ormigration is reduced. Additionally, in some instances, filling the voidcaused by surgical removal of the tumor with one of the devicesdescribed herein may be associated with a better cosmetic outcome asdescribed below.

In one exemplary aspect, the device comprises a plurality of grooves, aplurality of projections, and, optionally, one or more central channelsextending through the device body. Prior to placement within the tumorbed, one or more low-dose radioactive sources (e.g., seeds or strands)are secured in the grooves. As well, one or more low-dose radioactivesources and/or high-dose radioactive sources may be secured in thecentral channels. Once placed within the surgical site, the projectionshelp to anchor the device to prevent or minimize shifting, migration,rotation, or movement of the device during radiation delivery. This, inturn, enables a more accurate radiation delivery to the intended area ofthe patient's body.

In another exemplary aspect, the device comprises one or more hollowtubes having grooves and/or projections. In one configuration, thedevice comprises a single, continuous hollow tube formed into a helicalshape having a vacancy or space at its center. Radioactive seeds orstrands may be loaded into the tube channel before intra-operativeplacement. The grooves and/or projections may be used to anchor thedevice once placed within the tumor bed. In a second configuration, thedevice comprises a plurality of hollow tubes formed into, for example, aspherical or ellipsoid shape having a vacancy at its center. Radioactiveseeds or strands may be loaded into one or more of the tube channelsprior to intra-operative placement. The grooves and/or projections maybe used to anchor the device after placement.

Continuing with respect to the hollow tube configurations, because eachof these configurations has a vacancy at its center, it can beconsidered a non-space (or minimally space-) occupying device making ituseful in closed-space locations such as, for example, the brain toavoid increases in intracranial pressure. Further, the vacancy at thecenter of the device may allow for migration or influx of any blood,secretions, or other inflammatory fluids produced by the tumor bedthereby minimizing the opportunity for these fluids to accumulatebetween the tumor bed and the device wall which may decrease theeffectiveness of the radiation treatment.

The brachytherapy devices as contemplated herein provide a customizable,accurate, and sustained delivery of radiation while requiring minimalphysician and patient intervention after placement. Further, thebrachytherapy devices as contemplated herein may help minimize sideeffects due to, for instance, infection or radiation damage. As well, incases such as placement after a breast lumpectomy, the insertion of a3-D brachytherapy device may provide a pleasing cosmetic effect to thebreast.

The 2-D or 3-D device as described herein may also be used as astereotactic marker device. Stereotactic marker devices typicallycomprise one more radiopaque markers, and, once positioned within atumor site, the device may be used to guide, for example, external beamradiation. In one exemplary aspect, the devices described herein maycomprise both a brachytherapy device and a stereotactic marker device.With respect to this aspect, both radioactive seeds/strands andradiopaque markers can be placed in the device grooves, the devicecentral channels, or in the device tube channels. In other exemplaryaspects, the devices described herein may be used as just abrachytherapy device or as just a stereotactic marker device. As such,the term “brachytherapy device” as used herein may comprise both adevice used to deliver therapeutic radiation and/or a device that isuseable as a stereotactic marker.

Additional objects, advantages, and novel features of the invention willbe set forth in part in the description which follows, and in part willbecome apparent to those skilled in the art upon examination of thefollowing, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples of the present invention are described in detail below withreference to the attached drawing figures, wherein:

FIG. 1A illustrates a first exemplary brachytherapy device having athree-dimensional shape with protrusions and grooves extending acrossthe surface of the brachytherapy device in accordance with aspectsherein;

FIG. 1B illustrates a cross-section of a groove without and with aradioactive seed and/or a radiopaque marker positioned therein takenalong cut line 1B-1B of FIG. 1A in accordance with aspects herein;

FIG. 1C illustrates a cross-section of a protrusion taken along cut line1C-1C of FIG. 1A in accordance with aspects herein;

FIG. 2A illustrates a second exemplary brachytherapy device having athree-dimensional shape with protrusions and grooves extending acrossthe surface of the brachytherapy device in accordance with aspectsherein;

FIG. 2B illustrates a cross-section of a protrusion taken along cut line2B-2B of FIG. 2A in accordance with aspects herein;

FIGS. 3A-3C illustrate some exemplary cross-sectional shapes ofprotrusions in accordance with aspects herein;

FIG. 4A illustrates exemplary central channels of the brachytherapydevice of FIG. 1A in accordance with aspects herein;

FIG. 4B illustrates a cross-section of the exemplary central channels ofFIG. 4A taken along cut line 4B-4B in accordance with aspects herein;

FIG. 5A illustrates a first surface of a third exemplary brachytherapydevice having a two-dimensional shape with protrusions and grooves inaccordance with aspects herein;

FIG. 5B illustrates a second opposite surface of the third brachytherapydevice of FIG. 5A in accordance with aspects herein;

FIG. 6A illustrates a fourth exemplary brachytherapy device having ahelical shape formed form a single, continuous hollow tube and furtherhaving protrusions in accordance with aspects herein;

FIG. 6B illustrates an alternative configuration of the fourth exemplarybrachytherapy device having grooves instead of protrusions in accordancewith aspects herein;

FIG. 7 illustrates a cross-section of the hollow tube of thebrachytherapy device of, for example, FIG. 6A or 6B where thecross-section is taken along cut line 7-7 of FIG. 6A in accordance withaspects herein;

FIG. 8 illustrates a longitudinal cross-section of the hollow tube ofthe brachytherapy device of, for example, FIG. 6A or 6B both without andwith a radioactive seed and/or radiopaque marker positioned therein inaccordance with aspects herein;

FIG. 9A illustrates a fifth exemplary brachytherapy device having aspherical shape and formed from a plurality of hollow tubes and furtherhaving protrusions in accordance with aspects herein;

FIG. 9B illustrates an alternative configuration of the fifth exemplarybrachytherapy device having grooves instead of protrusions in accordancewith aspects herein;

FIG. 9C illustrates an alternative configuration of the fifth exemplarybrachytherapy device having a central column, hubs, and grooves inaccordance with aspects herein;

FIG. 10A illustrates a close-up view of a first exemplary configurationfor the hub of the fifth exemplary brachytherapy device of FIG. 9C;

FIG. 10B illustrates a close-up view of a second exemplary configurationfor the hub of the fifth exemplary brachytherapy device of FIG. 9C;

FIG. 11 illustrates an exemplary kit comprising at least radioactiveseeds/strands and/or radiopaque markers and one or more brachytherapydevices in a number of predetermined sizes in accordance with aspectsherein; and

FIG. 12 illustrates a flow diagram of an exemplary method of forming abrachytherapy device in accordance with aspects herein.

DETAILED DESCRIPTION

The subject matter of the present invention is described withspecificity herein to meet statutory requirements. However, thedescription itself is not intended to limit the scope of thisdisclosure. Rather, the inventors have contemplated that the claimed ordisclosed subject matter might also be embodied in other ways, toinclude different steps or combinations of steps similar to the onesdescribed in this document, in conjunction with other present or futuretechnologies. Moreover, although the terms “step” and/or “block” mightbe used herein to connote different elements of methods employed, theterms should not be interpreted as implying any particular order amongor between various steps herein disclosed unless and except when theorder of individual steps is explicitly stated.

As described above, aspects herein are directed to a bioabsorbableand/or biocompatible implantable brachytherapy device and/orstereotactic marker device having a plurality of protrusions and/orgrooves useable for anchoring the device within a tumor bed. In oneexemplary aspect, radioactive seeds may be positioned within one or moregrooves and/or one or more central channels on the brachytherapy deviceto deliver customizable amounts of radiation to the tumor bed. In analternative aspect, the radioactive seeds may be positioned withinchannels of one or more hollow tubes that form the brachytherapy device.When used as a stereotactic marker, radiopaque markers may be positionedwithin the grooves, central channels, or the tube channels. Adescription of the brachytherapy devices and/or stereotactic markerdevices is provided below with reference to the figures.

As used throughout this disclosure, the term “biocompatible device”means compatible with living tissue such that the biocompatible deviceis not toxic, is not physiologically reactive and generally does notcause an immunological reaction. The term “bioabsorbable device” as usedherein generally means a device that is biocompatible as defined aboveand that is capable of being absorbed into the patient's body over time.

In exemplary aspects, the brachytherapy devices described herein may beformed from a silicone (polysiloxane) polymer, silastic(polydimethylsiloxane), polyether ether ketones (PEEK), or mixtures ofpolysiloxane, polydimethylsiloxane, and PEEK. As well, the brachytherapydevice described herein may be formed from polyglycolic acid, Lpolylactic acid, D polylactic acid, or mixtures of L and D polylacticacid. In general, polysiloxane, polydimethylsiloxane, and PEEK may beused to form devices which are biocompatible, and polyglycolic acid andL and/or D polylactic acid may be used to form bioabsorbable devices.The brachytherapy devices described herein may be formed by, forexample, 3-D printing, using complementary molds, injection molding, andthe like. When the devices are configured to be bioabsorbable, materialsmay be selected and/or the devices may be configured such that thedevice absorbs at a rate that is at least four times the half-life ofany radioactive seeds/strands positioned on or in the device. Forinstance, Palladium 103 has a half-life of 17 days. In this instance,materials for the device would be selected and/or the device may beconfigured so that the device does not completely absorb for at least 68days. In one example, the amount of the L-isomer of polylactic acid maybe increased and the amount of the D-isomer may be decreased to slow therate of bioabsorption. Conversely, the amount of the L-isomer ofpolylactic acid may be decreased and the amount of the D-isomer may beincreased to increase the rate of bioabsorption.

The term “radioactive seed” as used herein refers to a single radiationsource that is positioned within a brachytherapy device. The term“radioactive strand” as used herein refers to multiple radiation sourcespositioned within a brachytherapy device, where the “strand” may be inthe form of an actual strand or tube. Radioactive seeds or strands maycomprise low-dose and/or high-dose radiation sources such as, forexample, palladium-103, iodine-125, cesium-131, gold-198, radium-223,yttrium-90, iridium-192, and the like. It is contemplated herein thatother active elements may be used in association with the brachytherapydevices described herein. An active element is an element that hastherapeutic properties for the treatment of a patient, such as, forexample, pharmaceutical, nuclear, or radioactive properties. Any and allaspects, and any variation thereof, are contemplated as being within thescope herein.

Aspect 1

With reference first to FIG. 1A, a brachytherapy device 100 isillustrated having a generally solid, three-dimensional (3-D) shape. Thebrachytherapy device 100 is configured to be permanently placed within atumor bed at the time of surgical resection of a tumor. The particularshape shown in FIG. 1A is a sphere but it is contemplated herein thatthe 3-D shape may comprise an ellipsoid shape, a cylindrical shape, andvariants thereof. The brachytherapy device 100 may be formed in a numberof predetermined sizes such as, for example, about 2 cm, 3 cm, 5 cm, or7 cm as measured across the maximum diameter of the device 100; the useof different sizes better accommodates different sizes of tumor beds. Abrachytherapy device having a 3-D shape, such as the device 100, may beparticularly useful in cancers such as breast or brain where the tumorbed generally comprises a three-dimensional shape. Further, because thebrachytherapy device 100 comprises a solid 3-D shape, it can beconsidered a space-occupying device. This may make the device 100especially useful following a breast lumpectomy. In this case, theplacement of a solid, 3-D device having a size corresponding to the sizeof the tumor bed may help to provide a pleasing aesthetic to the breastfollowing lumpectomy surgery by helping to fill the tumor cavity andpreventing or minimizing depressions on the exterior of the breast.

The materials described above for forming the brachytherapy devicesdescribed herein may cause the resulting brachytherapy device, such asthe brachytherapy device 100, to exhibit a degree of elasticdeformability (i.e., a temporary shape change that is self-reversingafter a stress is removed). In other words, the device 100, in exemplaryaspects, may not be completely rigid. By forming the device 100 to havea degree of elastic deformability, the brachytherapy device 100 may bebetter adapted to adjust to external pressures. This may be particularlyuseful when the brachytherapy device 100 is used in breast cancerpatients. For example, because the breast is often subject to externalpressures, using a device that exhibits some degree of elasticdeformability allows the breast to more comfortably adapt to externalpressures as opposed to using a rigid device. This, in turn, improvesthe patient's comfort.

The brachytherapy device 100 comprises a plurality of protrusions 110extending in a positive z-direction with respect to the surface plane ofthe device 100. As shown in FIG. 1A with reference to the Cartesiancoordinate system, the surface plane of the device 100 at any onelocation may be thought of as extending in an x direction and a ydirection (both positive and negative). The protrusions 110 extending ina positive z-direction would extend outward from the surface plane ofthe device 100. In exemplary aspects, the protrusions 110 are useable toanchor the brachytherapy device 100 in the tumor bed thereby minimizingor eliminating problems due to migration, motion, rotation, or shift inposition after intra-operative placement of the device 100. In oneexemplary aspect, the protrusions 110 are uniformly distributed over thesurface of the device 100. However, it is contemplated herein that theprotrusions 110 may be localized to one or more discrete areas of thedevice 100. Any and all aspects, and any variation thereof, arecontemplated as being within aspects herein.

Continuing with respect to the protrusions 110, and with reference toFIG. 1C which depicts a cross-section of a protrusion 110 taken alongcut line 1C-1C of FIG. 1A, the protrusions 110 may be integrally formedwith the brachytherapy device 100. In other words, they are formed ofthe same material as the brachytherapy device 100. However, it is alsocontemplated herein that the protrusions 110 may be formed by adding anadditional biocompatible and/or bioabsorbable treatment to the surfaceof the device 100. Each protrusion 110 has a conical shape with a basewidth or diameter 124 from about 0.9 mm to about 5.5 mm, or from about1.0 mm to about 5.0 mm. Further, each protrusion 110 may have a height126 from about 0.4 mm to about 5.1 mm, or from about 0.5 mm to about 5.0mm. As used herein, the term “about” means within ±10% of a designatedvalue.

With respect to FIG. 1A, the protrusions 110, in one exemplary aspect,are arranged in rows with each row extending from a first pole of thedevice 100 to a second opposite pole of the device 100. As such, theprotrusions 110 are generally uniformly distributed across the surfaceof the device 100. Each protrusion 110 may be spaced apart from anadjacent protrusion 110 in a particular row by a distance of from about1 mm to about 14 mm or from about 2 mm to about 12 mm. It iscontemplated herein that the rows of protrusions 110 may not extend allthe way from the first pole of the device 100 to the second oppositepole of the device 100 (i.e., the rows of protrusions 110 may extendonly partially between the poles of the device 100). It is furthercontemplated herein that the protrusions 110 may be not be configured inrows but may be randomly positioned on the device 100, and/or arrangedin some other pattern other than linear rows (e.g., curvilinear rows,zig-zag rows, sinusoidal rows, and the like). Any and all aspects, andany variation thereof, are contemplated as being within aspects herein.

With continued reference to FIG. 1A and with further reference to FIG.1B, which depicts a cross-section of a groove taken along cut line 1B-1Bof FIG. 1A, the brachytherapy device 100 further comprises a pluralityof grooves 114 extending in a negative z-direction with respect to thesurface plane of the device 100. That is, the grooves 114 extendinwardly with respect to the surface plane of the device 100. As shownin FIG. 1B, the grooves 114 are useable to hold in place looseradioactive seeds, radioactive strands, radiopaque markers, and/or otheractive elements 120. For example, the seeds, strands, markers, or activeelements 120 may be positioned within the grooves 114 and held in placethrough the use of a medical adhesive such as n-2-butyl-cyanoacrylate.As well, because the device 100 may exhibit some elastic deformability,the seeds, strands, markers, or active elements 120 may be biased ortensioned into the grooves 114 and held in place through the elastictension created by the biasing process. This may eliminate the need touse a medical adhesive in some exemplary aspects.

In general, loose radioactive seeds have a diameter of about 0.8 mm,while radioactive strands (radioactive seeds positioned within a tube ofbioabsorbable material) have a diameter of about 0.99 mm. With this ascontext, and with respect to FIG. 1B, the grooves 114 may have a width116 from about 0.75 mm to about 0.9 mm and a depth 118 from about 1.0 mmto about 1.2 mm when configured for use with loose radioactive seeds.Alternatively, the grooves 114 may have a width 116 from about 0.95 mmto about 1.1 mm and a depth 118 from about 1.0 mm to about 1.2 mm whenconfigured for use with radioactive strands. It is contemplated hereinthat the brachytherapy device 100 may have some grooves 114 configuredfor loose radioactive seeds and some grooves 114 configured forradioactive strands. Any and all aspects, and any variation thereof, arecontemplated as being within aspects herein.

Continuing, the grooves 114, in one exemplary aspect, are configured toextend from the first pole of the device 100 to the second opposite poleof the device 100. As such, the grooves 114, like the protrusions 110,are generally uniformly distributed across the surface of the device100. In one exemplary aspect, the rows of protrusions 110 alternate withthe grooves 114 to form a repeating pattern of “row ofprotrusions-groove-row of protrusions-groove,” and the like. However, itis contemplated herein that there may be other patterns such as twogrooves separated by a row of protrusions, two rows of protrusionsseparated by a groove, and the like. It is contemplated herein that thegrooves 114 may not extend all the way from the first pole of the device100 to the second opposite pole of the device 100 (i.e., the grooves 114may extend only partially between the poles of the device 100). It isfurther contemplated herein that the grooves 114 may be randomlypositioned on the device 100, and/or arranged in some other pattern thanthat shown in FIG. 1A (e.g., curvilinear, zig-zag, sinusoidal, and thelike). Any and all aspects, and any variation thereof, are contemplatedas being within aspects herein.

As shown in FIG. 4A, which depicts the device 100 without anyprotrusions or grooves for illustrative purposes, and as further shownin FIG. 4B, which depicts a cross-section of the device 100 taken acrosscut line 4B-4B of FIG. 4A, the device 100 may optionally comprise one ormore central channels 410 that extend through the body of the device100. With respect to FIG. 4A in particular, a central channel, such ascentral channel 416, may extend from a first surface location 412 on oneside the device 100, through the body of the device 100, to a secondsurface location 414 on the device 100 where the second surface location414 is opposite the first surface location 412. The central channels 410thereby form through passages in the device 100 as shown in FIG. 4B. Inone exemplary aspect, one or more of the central channels 410 may beconfigured to pass through a maximum diameter of the device 100. Thecentral channels 410 may number from about 1 to 12 and may have adiameter 418 from about 0.7 mm to about 1.2 mm, or from about 0.8 mm toabout 1.1 mm.

The central channels 410 are useable for additional seed, strand,radiopaque marker, and/or active element placement. Similar to thegrooves, the radioactive seeds/strands/markers/elements may be held inthe central channels 410 via a medical adhesive, or the radioactiveseeds/strands/markers/elements may be biased into the central channels410 and held in place via the elastic tension created by the biasingprocess. In one exemplary aspect, high dose radiation seeds, such asseed 415 in FIG. 4A, may be placed in one or more of the centralchannels 410 while low dose radiation seeds may be positioned in thegrooves 114. Because the central channels 410 are positioned furtheraway from the tumor bed as compared to the grooves 114, some of thedamaging effects of the higher dose radiation seeds may be lessenedbased on the inverse-square law which generally states that theintensity of the radiation is inversely proportional to the square ofthe distance from the radioactive source. It is also contemplated hereinthat low dose radiation seeds may also be placed in the central channels410. Any and all aspects, and any variation thereof, are contemplated asbeing within aspects herein.

FIG. 2A illustrates another exemplary brachytherapy device 200 inaccordance with aspects herein. The device 200 shares the same featuresas the device 100 including grooves 212 and protrusions 210 andoptionally central channels. The main difference between the device 200as compared to the device 100 is that the protrusions 210 have agenerally cylindrical shape as opposed to a conical shape as in FIG. 1.In this exemplary aspect, and as shown in FIG. 2B which represents across-section of a protrusion 210 taken along cut line 2B-2B of FIG. 2A,the protrusions 210 may have a uniform width or diameter 214 from about0.9 mm to about 5.5 mm, or from about 1.0 mm to about 5.0 mm and aheight 216 from about 0.4 mm to about 5.1 mm, or from about 0.5 mm toabout 5.0 mm.

It is contemplated herein that the device 100 or the device 200 (or anyof the other devices described herein) may have other shapeconfigurations for the protrusions. FIGS. 3A-3C illustrate someadditional exemplary shapes. For example, FIG. 3A depicts a protrusion310 having a semi-hemispherical shape. FIG. 3B depicts a protrusion 312having a planar distal surface that comprises a greater surface areathan the base of the protrusion 312 (i.e., the protrusion 312 expandsoutward), while FIG. 3C depicts a protrusion 314 having a planar distalsurface that comprises a smaller surface area than the base of theprotrusion 314 (i.e., the protrusion 314 tapers as it extends outward).Additional shape configurations beyond those shown are contemplated asbeing within aspects herein.

Aspect 2

Turning now to FIGS. 5A and 5B, a brachytherapy device 500 is shown ashaving a generally two-dimensional (2-D) planar shape comprising a firstplanar surface 510 shown in FIG. 5A, and a second planar surface 512opposite the first planar surface 510 shown in FIG. 5B. The device 500further comprises one or more sides 514 extending between, and generallyperpendicular to, the first planar surface 510 and the second planarsurface 512. In exemplary aspects, the sides 514 may have a height fromabout 2.0 mm to about 4.0 mm. In other words, the device 500 may have athickness from about 2.0 mm to about 4.0 mm. The use of a device havinga 2-D planar shape may be especially useful in tumors such as sarcomaswhere the tumor bed generally comprises a one-dimensional planarsurface.

Although the brachytherapy device 500 is shown in a rectangular form,the device 500 may also comprise a square form. When the device 500 isin the form of a square, the device 500 may be formed in a number ofpredetermined sizes such as about 2×2 cm, 4×4 cm, 6×6 cm, 8×8 cm, or10×10 cm. When the device 500 is in the form of a rectangle, the device500 may be formed in a number of predetermined sizes such as about 2×4cm, 2×6 cm, 4×6 cm, 4×8 cm, 4×10 cm, 6×8 cm, or 6×10 cm. It is alsocontemplated herein that the device 500 may be formed into other shapessuch as a 2-D planar circle, a 2-D planar ellipse, and the like. It isfurther contemplated herein that the device 500 may be cut to shape orformed to shape at the time of intra-operative placement. This may beuseful for tumor beds having an irregular shape. Any and all aspects,and any variation thereof, are contemplated as being within aspectsherein.

In one exemplary aspect, the device 500 may comprise a plurality ofprotrusions 516 useable for anchoring the device 500 in a tumor bed. Theplurality of protrusions 516 may extend in a positive z-direction from,for example, the first planar surface 510, the sides 514, and the secondplanar surface 512 of the device 500 and may be integrally formed fromthe same materials used to form the device 500. Alternatively, theprotrusions 516 may be formed by adding an additional biocompatible orbioabsorbable treatment to the surface of the device 500. Theprotrusions 516 may be conical in shape and may have similar dimensionsas those described for the protrusions 110 of the device 100.Alternatively, the protrusions 516 may have a cylindrical shape such asthat shown for the device 200 or may have one of the shapeconfigurations shown in FIGS. 3A-3C. In one exemplary aspect, theprotrusions 516 may be arranged in linear rows along the first planarsurface 510, along the sides 514, and along the second planar surface512, where the rows extend from a first end of the device 500 to asecond end of the device 500. Although linear rows of protrusions 516are shown for the device 500, it is contemplated herein that theprotrusions 516 may be randomly positioned on the device 500 or mayassume other patterns than those shown (e.g., curvilinear rows, zig-zagrows, sinusoidal rows, and the like). Moreover, it is contemplatedherein that the rows of protrusions 516 may not extend all the way tothe first and second ends of the device 500. Any and all aspects, andany variation thereof, are contemplated as being within aspects herein.

The device 500 may further comprise a plurality of grooves 518 havingsimilar dimensions as those described for the grooves 114 of the device100 where the grooves 518 are useable for securing radioactive seeds,strands, radiopaque markers, and/or active elements. Although only twogrooves 518 are shown, it is contemplated herein that the device 500 maycomprise any number of grooves. In exemplary aspects, the grooves 518may be positioned on just the first planar surface 510, where the firstplanar surface 510 is configured to be positioned adjacent to the tumorbed when placed intra-operatively. It is also contemplated herein thatthe grooves 518 may be positioned on the second planar surface 512and/or along one or more of the sides 514 of the device 500. In oneexemplary aspect, the grooves 518 extend from a first end of the device500 to a second end of the device 500 along its longitudinal axis.However, it is contemplated herein that the grooves 518 may extend onlypartially between the first and second ends of the device 500 or mayextend widthwise across the device 500 when the device 500 comprises arectangular shape. Although the grooves 518 are shown as being linear inform, it is contemplated herein that the grooves 518 may comprise othershapes such as curvilinear, sinusoidal, zig-zag, and the like. Any andall aspects, and any variation thereof, are contemplated as being withinaspects herein. Similar to the device 100, a particular groove 518 mayalternate with a row of protrusions 516 to form a repeating pattern. Itis contemplated herein that the grooves 518 and the protrusions 516 mayassume other patterns as well such as, for example, groove-groove-row ofprotrusions, and the like.

Aspect 3

FIG. 6A illustrates another brachytherapy device 600 in accordance withaspects herein. The device 600 comprises a single, continuous, hollowtube 610 formed into a helix having a spherical shape as shown. It isalso contemplated herein that the tube 610 may be formed into othershapes such as a cylindrical shape, an ellipsoid shape, a disc shape,and the like. The device 600 may come in a number of predetermined sizessuch as sizes having a diameter of about 2 cm, 3 cm, 5 cm, or 7 cm.

As described above, features of the device 600 such as materialcomposition or device configuration may be altered to increase ordecrease the time it takes for the device 600 to bioabsorb. In oneexample, a thickness of the walls forming the tube 610 may be increasedto slow the rate of bioabsorption, and a thickness of the walls may bedecreased to increase the rate of bioabsorption. Additionally, oralternatively, the percentage of, for instance, the D-isomer ofpolylactic acid or the L-isomer of polylactic acid may be increased ordecreased to alter the rate of bioabsorption.

Continuing, because of its helical form, the device 600 has a vacancy atits center. That is, the device 600 is generally a non-space occupying(or minimally-space occupying) device. Since it generally occupies lessspace as compared to, for instance, the device 100, this configurationmay be useful for placement in tumor beds where an increase in pressureis generally avoided (e.g., brain tumors). Moreover, the vacancy at thecenter of the device 600 may also act as a repository for anyaccumulation of bloods, secretions, and inflammatory fluids therebypreventing or minimizing the buildup of these materials in the spacebetween the device 600 and the tissue of the tumor bed. This may help toimprove the efficacy of the device 600 by allowing the radioactiveseeds/strands to be positioned closer to the tumor bed.

In exemplary aspects, the tube 610 has a continuous, central channel(i.e., bore) 711 extending at least partially or completely along thelength of the tube 610 where the channel 711 is useable for receivingradioactive seeds, strands, radiopaque markers, and/or active elements.This aspect is shown in FIGS. 7 and 8 where FIG. 7 depicts across-section of the tube 610 taken along cut line 7-7 of FIG. 6A, andFIG. 8 depicts a longitudinal cross-section of the tube 610. As shown inFIGS. 7 and 8, the outer diameter 710 of the tube 610 may be from about3.0 mm to about 9.0 mm, or from about 4.0 mm to about 8.0 mm. And adiameter 712 of the channel 711 located in the tube 610 is from about1.1 mm to about 1.5 mm, or from about 1.2 mm to about 1.4 mm.

Continuing, the tube 610 may have at least one open end in whichradioactive seeds, radioactive strands, radiopaque markers, and/oractive elements may be placed and secured using, for example, a medicaladhesive at the time of placement in the tumor bed. With respect to thisaspect, the open end of the tube 610 may be secured using, for example,a clip, a plug, a medical adhesive, and the like. Alternatively, thetube 610 may be pre-loaded with radioactive seeds, strands, radiopaquemarkers, and/or active elements during manufacturing. When pre-loaded,the tube ends may be sealed prior to shipping. With respect to FIG. 8,the channel 711 extends along at least a portion of the length of thetube 610 and is useable for receiving seeds, strands, markers, and/oractive elements as shown by reference numeral 810 in FIG. 8. It is alsocontemplated herein that the channel 711 extends along an entire lengthof the tube 610. Any and all aspects, and any variation thereof, arecontemplated as being within aspects herein.

Returning to FIG. 6A, in one exemplary aspect, the device 600 comprisesa plurality of conical protrusions 612 extending in a positivez-direction with respect to the surface plane of the tube 610. Theprotrusions 612 have similar dimensions as to those described for thedevice 100 or the device 500. Alternatively, the protrusions 612 mayhave a cylindrical form as depicted for the device 200, or theprotrusions 612 may comprise other configurations such as those shown inFIGS. 3A-3C. In exemplary aspects, the protrusions 612 are configured toextend away from the center of the device 600. To describe thisdifferently, the protrusions 612 may be positioned on just one side ofthe tube 610—the side that faces away from the center of the device 600(also known as the outer-facing surface of the tube 610). It is alsocontemplated herein that the protrusions 612 may be positioned on thetube 610 such that they extend both away from the center of the device600 and toward the center of the device 600. Any and all aspects, andany variation thereof, are contemplated as being within aspects herein.Similar to the devices already described, the protrusions 612 areconfigured to anchor the device 600 in, for example, a tumor bed tominimize migration, rotation, or shifting of the device 600.

FIG. 6B depicts a brachytherapy device 650 having a similarconfiguration as the brachytherapy device 600 but having grooves 652instead of protrusions, where the grooves 652 are useable for anchoringthe brachytherapy device 650. As shown in the magnified view, thegrooves 652 extend in a negative z-direction with respect to the surfaceplane of the tube 610. Each groove 652 may have a width from about 0.1mm to about 2.0 mm, and each groove 652 may have a depth from about 0.1mm to about 2.0 mm. In exemplary aspects, the grooves 652 may berotationally positioned along the tube 610. To state it differently, thegrooves 652 may extend in a helical fashion or a corkscrew manner alongthe length of the tube 610. However, it is contemplated that the grooves652 may be arranged in other patterns on the tube 610 and may extendonly partially along the length of the tube 610. The grooves 652contribute to making the outer surface of the tube 610 irregular orrough which, in turn, helps to anchor the device 650 in the tumor bed.For example, the grooves 652 may help to promote tissue ingrowth therebyhelping to anchor the device 650. It is further contemplated herein thatother features besides grooves may be used to create a rough outersurface of the tube 610. For example, the outer surface of the tube 610may be molded or formed to have ridges, braids, or some other type oftexture. In another aspect, an additional bioabsorbable or biocompatibletreatment may be applied to the outer surface of the tube 610 to createthe rough surface. Any and all aspects, and any variation thereof, arecontemplated as being within aspects herein.

Aspect 4

FIG. 9A illustrates a brachytherapy device 900 in accordance withaspects herein. The device 900 comprises a plurality of hollow tubes 910that are formed into a spherical shape having a first pole 912 and asecond opposite pole 916. Although shown in a spherical shape, it iscontemplated herein that the device 900 may comprise other shapes suchas a 3-D ellipsoid shape, a 3-D cylindrical shape, a 2-D disc shape, andthe like. Similar to the device 600, the device 900 may be formed insuch a way as to increase or decrease the time it takes for the device900 to bioabsorb. For example, a thickness of the walls forming thetubes 910 may be increased to slow the rate of bioabsorption, and athickness of the walls may be decreased to increase the rate ofbioabsorption. Additionally, or alternatively, the percentage of, forinstance, the D-isomer of polylactic acid or the L-isomer of polylacticacid may be increased or decreased to alter the rate of bioabsorption.

The device 900 may be formed using the same materials as described withrespect to the devices 100, 200, 500, 600, or 650 and, as such, may bebiocompatible and/or bioabsorbable and may exhibit a degree of elasticdeformation. Similar to the devices 600 and 650, the device 900 has avacancy at its center. That is, the device 900 is generally a non-spaceoccupying (or minimally-space occupying) device. Because of this, thedevice 900 may have the same functional advantages as detailed for thedevices 600 and 650.

The device 900 may be manufactured in a number of predetermined sizeshaving diameters such as about 2 cm, 3 cm, 5 cm, or 7 cm. With respectto the device 900, each tube 910, such as tube 911, comprises a firstend 913 and a second end 915, and an intervening portion extendingbetween the first end 913 and the second end 915. In exemplary aspects,the respective first ends of the tubes 910 are interconnected at thefirst pole 912, and the respective second ends of the tubes 910 areinterconnected at the second pole 916. This may be accomplished through,for example, a molding process or a 3-D printing process. In exemplaryaspects, the intervening portions of the tubes are spaced apart from oneanother by a predetermined distance such as from about 0.05 mm to about11 mm, or from about 1 mm to about 10 mm.

Each of the tubes 910 has a continuous, central channel (i.e., bore)extending at least partially along or completely along the length of therespective tube 910. A cross-section of one of the tubes 910 would besimilar to that shown in FIG. 7, and a longitudinal cross-section of oneof the tubes 910 would be similar to that shown in FIG. 8. In exemplaryaspects, the outer diameter of the tubes 910 is from about 3.0 mm toabout 9.0 mm, or from about 4.0 mm to about 8.0 mm. And the diameter ofthe channel located in the respective tubes 910 is from about 1.1 mm toabout 1.5 mm, or from about 1.2 mm to about 1.4 mm. The tubes 910 mayhave at least one open end in which radioactive seeds, radioactivestrands, radiopaque markers, and/or active elements may be placed andsecured using, for example, a medical adhesive at the time ofintra-operative placement. Similar to the devices 600 and 650, the openends of the tubes 910 may be secured using, for example, a clip.Alternatively, the tubes 910 may be pre-loaded with radioactive seeds,strands, radiopaque markers, and/or active elements during manufacturingand the open ends of the tubes 910 may be sealed prior to shipping.

In exemplary aspects, one or more of the tube channels may be left empty(i.e., not loaded with a radioactive seed or strand) to protect nearbystructures once the brachytherapy device 900 is implanted in the tumorbed. For instance, when used after a breast lumpectomy, tube channelsnot containing a radioactive seed or strand may be positioned in thetumor bed so as to be adjacent to, for instance, the chest wall, asopposed to the tumor bed. This may help to lessen the effects ofradiation on these structures.

In one exemplary aspect and as shown in FIG. 9A, the device 900comprises a plurality of conical protrusions 914 extending in a positivez-direction with respect to the surface plane of the tubes 910. Theprotrusions 914 have similar dimensions as to those described for thedevice 100. Alternatively, the protrusions 914 may have a cylindricalform as depicted for the device 200 or may assume other shapeconfigurations such as those shown in FIGS. 3A-3C. In exemplary aspects,the protrusions 914 are configured to extend away from the center ormiddle of the device 900. Similar to the devices already described, theprotrusions 914 are configured to anchor the device 900 in, for example,a tumor bed to minimize migration or shifting of the device 900.

An alternative configuration where grooves are used instead ofprotrusions is shown in FIG. 9B. FIG. 9B illustrates a device 925 withgrooves 927 that are useable for anchoring the brachytherapy device 925.Similar to what was discussed with respect to the device 650, thegrooves 927 extend in a negative z-direction with respect to the surfaceplane of the tubes 910. Each groove 927 may have a width from about 0.1mm to about 2.0 mm, and each groove 927 may have a depth from about 0.1mm to about 2.0 mm. In exemplary aspects, the grooves 927 may berotationally positioned along the tubes 910. To state it differently,the grooves 927 may extend in a helical fashion or a corkscrew manneralong the length of the tubes 910. However, it is contemplated that thegrooves 927 may be arranged in other patterns on the tubes 910 or mayextend only partially along the length of the tubes 910. The grooves 927contribute to making the outer surface of the tubes 910 irregular orrough which, in turn, helps to anchor the device 925 in the tumor bed.For example, the grooves 927 may help to promote tissue ingrowth therebyhelping to anchor the device 925. It is further contemplated herein thatother features besides grooves may be used to create a rough outersurface of the tubes 910. For example, the outer surface of the tubes910 may be molded or formed to have ridges, braids, or some other typeof texture. In another aspect, an additional bioabsorbable orbiocompatible treatment may be applied to the outer surface of the tubes910 to create the rough surface. Any and all aspects, and any variationthereof, are contemplated as being within aspects herein.

Yet another alternative exemplary configuration is shown in FIG. 9C inaccordance with aspects herein. Similar to the devices 900 and 925, thedevice 950 comprises a plurality of hollow tubes 952 that are formedinto a spherical shape having a first pole 954 and a second oppositepole 956. The device 950 further comprises a central column 957 thatextends through the center of the device 950 and terminates in a firstplanar hub 958 at the first pole 954 and a second planar hub 960 at thesecond pole 956. In exemplary aspects, the central column 957 providesadditionally stability to the device 950.

Continuing, in a first aspect, the central column 957 may comprise acontinuous channel or bore extending partially or completely along thelength of the central column 957. A cross-section of the central column957 in accordance with the first aspect would be similar to that shownin FIG. 7 (minus the protrusion 612), and a longitudinal cross-sectionof the central column 957 would be similar to that shown in FIG. 8(minus the protrusions 612). With respect to this aspect, the channelmay be useable for receiving a radioactive seed, radioactive strand,radiopaque marker, and/or active element. In a second aspect, thecentral column 957 may be solid (i.e., not comprising a channel). Anyand all aspects, and any variation thereof, are contemplated as beingwithin aspects herein. In exemplary aspects, the central column 957 hasa length generally equal to or slightly greater than the diameter of thedevice 950. For instance, if the diameter of the device comprises about3 cm, the central column may have a length from about 3.0 cm to about3.5 cm, from about 3.0 cm to about 3.3 cm, or from about 3.0 cm to about3.1 cm. Further, in exemplary aspects, the central column 957 may becapped with or may terminate in an optional protrusion 959 at eachrespective end of the column 957, where the protrusion 959 is useablefor helping to anchor the device 950.

Continuing, each of the tubes 952 has a continuous, central channel(i.e., bore) extending at least partially or completely along the lengthof the respective tube 952. A cross-section of one of the tubes 952would be similar to that shown in FIG. 7 (minus the protrusion 612), anda longitudinal cross-section of one of the tubes 952 would be similar tothat shown in FIG. 8 (minus the protrusions 612). In exemplary aspects,the outer diameter of the tubes 952 is from about 3.0 mm to about 9.0mm, or from about 4.0 mm to about 8.0 mm. And the diameter of thechannel located in the respective tubes 952 is from about 1.1 mm toabout 1.5 mm, or from about 1.2 mm to about 1.4 mm. The channel of thetubes 952 is useable to receive a radioactive seed and/or strand, aradiopaque marker, and/or an active element.

Instead of having protrusions extending from the surface of the tubes952 as described for the device 900, the tubes 952 may instead comprisegrooves 962 similar to the brachytherapy device 925. The grooves 962extend in a negative z-direction with respect to the surface plane ofthe tubes 952. In exemplary aspects, the grooves 962 may be rotationallypositioned along the tubes 952. To state it differently, the grooves 962may extend in a helical fashion or a corkscrew manner along the lengthof the tubes 952. However, it is contemplated that the grooves 962 maybe arranged in other patterns on the tubes 952 and may extend onlypartially along the length of the tubes 952. The grooves 962 contributeto making the outer surface of the tubes 952 irregular or rough which,in turn, helps to anchor the device 950 in the tumor bed. For example,the grooves 962 may help to promote tissue ingrowth thereby helping toanchor the device 950. It is further contemplated herein that otherfeatures besides grooves may be used to create a rough outer surface ofthe tubes 952. For example, the outer surface of the tubes 952 may bemolded or formed to have ridges, braids, or some other type of texture.In another aspect, an additional bioabsorbable or biocompatibletreatment may be applied to the outer surface of the tubes 952 to createthe rough surface. Any and all aspects, and any variation thereof, arecontemplated as being within aspects herein.

With respect to the first planar hub 958 and the second planar hub 960,aspects herein contemplate a number of different configurations for thehubs 958 and 960 as shown by FIGS. 10A and 10B. FIG. 10A depicts anexemplary hub 1000 having a first surface 1010, a second surface 1012opposite the first surface 1010, and a side wall 1014 extendingtherebetween. The exemplary hub 1000 may comprise the first planar hub958 and/or the second planar hub 960. The side wall 1014 of the hub 1000further comprises a plurality of receiving holes 1016 evenly spacedaround the circumference of the hub 1000. Each receiving hole 1016extends a predetermined distance towards the center of the hub 1000(shown by the dashed lines). Exemplary distances may comprise, forexample, from about 2 mm to about 10 mm, from about 2 mm to about 8 mm,or from about 2 mm to about 5 mm. In general, the number of receivingholes 1016 is equal to the number hollow tubes 952 forming thebrachytherapy device 950 (excluding the central column).

In use, the tubes 952 may be loaded with radioactive seeds or strands,radiopaque markers, and/or active elements and the tube ends may be fedinto the receiving holes 1016 and secured using, for instance, a medicaladhesive. This step may occur at, for instance, the manufacturingfacility making the brachytherapy device 950 or may occur at the time ofintra-operative placement.

FIG. 10B depicts an alternative configuration for the planar hubs 958and/or 960 in accordance with aspects herein. FIG. 10B depicts a hub1050 having a first surface 1052, a second surface 1054 opposite thefirst surface 1052, and a side wall 1056 extending therebetween. Theside wall 1056 of the hub 1050 further comprises a plurality ofreceiving holes 1058 evenly spaced around the circumference of the hub1050. Each receiving hole 1058 extends to the center of the hub 1050(shown by the dashed lines). To describe this differently, each hole1058 extends to the central column 957. In general, the number ofreceiving holes 1058 is equal to the number hollow tubes 952 forming thebrachytherapy device 950 (excluding the central column).

Similar to the planar hub 1000, in use the tubes 952 may be loaded withradioactive seeds or strands, radiopaque markers, and/or active elementsand the tube ends may be fed into the receiving holes 1058 and securedusing, for instance, a medical adhesive. This step may occur at, forinstance, the manufacturing facility making the brachytherapy device 950or may occur at the time of intra-operative placement.

Aspect 5

Turning now to FIG. 11, aspects herein further contemplate abrachytherapy kit 1100. In exemplary aspects, the kit 1100 includes aplurality of brachytherapy devices 1110 such as the device 100, thedevice 200, the device 300, the devices 600 and 650, and/or the devices900, 925, and 950 in a number of predetermined sizes as described above.The kit 1100 further includes loose radioactive seeds (high dose and lowdose) 1112, radioactive strands (high dose and low dose) 1114,radiopaque markers (not shown), and/or other types of active elements(not shown). The kit 1100 may optionally include a medical adhesive1116, computer software useable for determining an appropriate radiationdose and/or an appropriate device configuration to use (not shown),and/or Babcok forceps with long arms for placement of the loadedbrachytherapy device in the tumor bed (not shown). The brachytherapy kit1100 would come in a sterile form and is meant to be used in theoperating room during the resection of a tumor.

In a use scenario, a surgeon and a radiation oncologist would be presentin the operating room. After the tumor is removed and a preliminaryreading is received from the pathologist, the radiation oncologist woulddetermine the appropriate type, shape and size of the brachytherapydevice depending on the size and shape configuration of the tumor bedand where the tumor bed is located. For instance, when the tumor islocated in the brain, the radiation oncologist may select thebrachytherapy device 600, 650, 900, 925, or 950 since these arenon-space occupying (or minimally-space occupying) devices, and thesedevices would generally not increase pressure in the organ in which theyare placed (an important consideration in the brain). In anotherexample, when the tumor is located in the breast, the radiationoncologist may select the brachytherapy device 100 or 200. By using asolid, space-occupying device with this type of tumor, the device mayhelp to fill the tumor bed and produce a better visual aesthetic to thebreast after lumpectomy. In yet another example, when the tumor is asarcoma or other similar types of tumor, the radiation oncologist mayselect the brachytherapy device 300. By using a 2-D shape with groovesand seeds located on just one planar surface, the device can bepositioned such that the radioactive seeds are next to the tumor bed andnot adjacent to healthy tissue.

Continuing, the radiation oncologist would also determine an appropriateradiation dose depending on the grade of the tumor. Based on this, theradiation oncologist would load the selected brachytherapy dose with theappropriate dose of radiation using the seeds 1112 and/or strands 1114in the kit 1100. The loaded brachytherapy device would then bepositioned within the tumor bed by the surgeon, and the surgeon wouldproceed with closing the surgical wound.

It is also contemplated herein that the kit 1100 may come with a varietyof pre-loaded brachytherapy devices in one or more sizes and shapeconfigurations. In other words, the radioactiveseeds/strands/markers/elements would be positioned in or on thebrachytherapy device at the time of manufacture and the pre-loadeddevices would then be shipped. It is also contemplated herein, thatbrachytherapy kits may be customized based on tumor type. For instance,there may be a breast brachytherapy kit having devices such as device100 and/or device 200 in a number of predetermined sizes. There may be abrain brachytherapy kit having devices 600, 650, 900, 925, and/or 950 ina number of predetermined sizes. As well, there may be a sarcomabrachytherapy kit having device 300 in a number of predetermined sizes.These are just illustrative examples, and it is contemplated thatbrachytherapy kits may be customized for any number and type of tumors.

Aspect 6

Aspects herein further contemplate a method of manufacturing abrachytherapy device as shown in FIG. 12. FIG. 12 depicts a flow diagramof an exemplary method 1200 of manufacturing a brachytherapy device,such as any of the brachytherapy devices 100, 200, 500, 600, 650, 900,925, or 950 in accordance with aspects herein. At a step 1210, amaterial is provided. The material may comprise a silicone(polysiloxane) polymer, silastic (polydimethylsiloxane), PEEK,polyglycolic acid, L or D polylactic acid, or any combination thereof.

Continuing, in one exemplary aspect and as indicated at a step 1212, thematerial is formed into a brachytherapy device having grooves,protrusions, and optional central channels such as illustrated for thebrachytherapy devices 100, 200, and 500. In another exemplary aspect,and as indicated at a step 1214, the material is formed into abrachytherapy device having one or more hollow tubes with grooves orprotrusions on the outer surface of the tubes such as illustrated forthe brachytherapy devices 600, 650, 900, 925, and 950. The material maybe formed into a brachytherapy device using complementary molds,injection molding, 3-D printing, and the like. The steps 1212 and 1214may further comprise an optional curing step. In one exemplary aspect,the steps 1210, 1212 or 1214 may take place at a manufacturing facility.When done at a manufacturing facility, the brachytherapy device may beformed into one of the device configurations shown for the devices 100,200, 500, 600, 650, 900, 925, and 950 and may be further formed into oneof a predetermined number of sizes as described above.

Continuing, in another exemplary aspect, the steps 1210, 1212 or 1214may take place in an operating room setting at the time a tumor is beingremoved. This may be particularly useful for when the tumor bed has anirregular shape that does not correspond to the shapes/configurationsassociated with the devices 100, 200, 500, 600, 650, 900, 925, and 950.Exemplary tumors that may fall within this category include, forexample, sacral convexity tumors, paraspinal tumors, and irregularshaped brain tumors. To provide effective radiation delivery for thesetypes of tumors, a brachytherapy device having a customized shape may beuseful. In exemplary aspects, the tumor bed may be scanned using forexample, known laser scanning techniques, and the information inputtedinto a 3-D printer. The 3-D printer would be utilized to form abrachytherapy device having a shape corresponding to the shape of thetumor bed and having one or more of the features describes for thebrachytherapy devices 100, 200, 500, 600, 650, 900, 925, or 950.

The method 1200 may further comprise, at a step 1216, positioning one ormore radioactive seeds, strands, radiopaque markers, and/or activeelements within one or more grooves of the brachytherapy device orwithin one or more channels when the brachytherapy device is formedusing hollow tubes. In one exemplary aspect, the formed and loadedbrachytherapy device may be packaged separately or as part of a kit andshipped to its destination end point. In an alternative step, the formedbrachytherapy device may not be pre-loaded and, instead, may be packagedseparately or as part of a kit and shipped to its destination end point.With respect to this aspect, the brachytherapy device may be loaded withradioactive seeds/strands or radiopaque markers at the time ofintra-operative placement. Any and all aspects, and any variationthereof, are contemplated as being within aspects herein.

Aspects of the present disclosure have been described with the intent tobe illustrative rather than restrictive. Alternative aspects will becomeapparent to those skilled in the art that do not depart from its scope.A skilled artisan may develop alternative means of implementing theaforementioned improvements without departing from the scope of thepresent invention.

It will be understood that certain features and subcombinations are ofutility and may be employed without reference to other features andsubcombinations and are contemplated within the scope of the claims. Notall steps listed in the various figures need be carried out in thespecific order described.

What is claimed is:
 1. A brachytherapy device comprising: a plurality oftubes arranged in a spherical or ellipsoid form, each tube of theplurality of tubes having a respective first end and a respective secondend, wherein the first ends of the tubes are joined at a first pole ofthe spherical or ellipsoid form, and wherein the second ends of thetubes are joined at a second opposite pole of the spherical or ellipsoidform, each tube having a continuous channel extending along at least aportion of its length.
 2. The brachytherapy device of claim 1, whereinthe brachytherapy device comprises one of a bioabsorbable material or abiocompatible material.
 3. The brachytherapy device of claim 2, whereinthe biocompatible material is polysiloxane, polydimethylsiloxane,polyether ether ketones, or mixtures thereof.
 4. The brachytherapydevice of claim 2, wherein the bioabsorbable material is polyglycolicacid, L polylactic acid, D polylactic acid, or mixtures of L polylacticacid and D polylactic acid.
 5. The brachytherapy device of claim 1,further comprising, a plurality of grooves extending in a negativez-direction with respect to an outer surface plane of at least a portionof the plurality of tubes.
 6. The brachytherapy device of claim 5,wherein each groove of the plurality of grooves is rotationallypositioned along a respective tube of the plurality of tubes.
 7. Thebrachytherapy device of claim 1, further comprising a plurality ofprotrusions extending in a positive z-direction with respect to an outersurface plane of at least a portion of the plurality of tubes.
 8. Thebrachytherapy device of claim 7, wherein the plurality of protrusionsextend away from a center of the spherical or ellipsoid form.
 9. Thebrachytherapy device of claim 8, wherein each protrusion of theplurality of protrusions has a base width from about 1.0 to about 5.0 mmand a height from about 0.5 mm to about 5.0 mm.
 10. The brachytherapydevice of claim 1, further comprising: one or more radioactive seedspositioned within one or more of the tube channels.
 11. Thebrachytherapy device of claim 1, wherein an outer diameter of the eachtube is from about 4.0 mm to about 8.0 mm.
 12. The brachytherapy deviceof claim 11, wherein a diameter of the each channel is from about 1.0 mmto about 1.3 mm.
 13. The brachytherapy device of claim 1, wherein amaximum diameter of the brachytherapy device is one of about 2 cm, 3 cm,5 cm, or 7 cm.
 14. A brachytherapy device comprising: a plurality oftubes arranged in a three-dimensional (3-D) form, at least a portion ofthe plurality of tubes having a channel extending along at least aportion of the length of the tube, each tube of the plurality of tubeshaving a first end, a second end, and an intervening portion extendingbetween the first end and the second end, wherein: respective first endsof the plurality of tubes are joined at a first location on the 3-Dform, respective second ends of the plurality of tubes are joined at asecond location on the 3-D form, and at least a portion of the pluralityof tubes comprise a groove extending in a negative z-direction withrespect to an outer surface plane of the tube.
 15. The brachytherapydevice of claim 14, wherein respective intervening portions of theplurality of tubes are spaced apart from one another.
 16. Thebrachytherapy device of claim 14, wherein there is a vacancy at a centerportion of the 3-D form.
 17. The brachytherapy device of claim 14,further comprising one or more of a radioactive seed and a radioactivestrand positioned in the channel of a tube of the plurality of tubes.18. The brachytherapy device of claim 14, wherein the respective firstends of the plurality of tubes are joined together via a first hub,wherein the respective second ends of the plurality of tubes are joinedtogether via a second hub, and wherein a central column joins the firsthub to the second hub.
 19. A method of manufacturing a brachytherapydevice, the method comprising: providing a biocompatible material or abioabsorbable material; and forming the material into the brachytherapydevice comprising a plurality of tubes arranged in a spherical orellipsoid form, each tube of the plurality of tubes having a respectivefirst end and a respective second end, wherein the first ends of thetubes are joined at a first pole of the spherical or ellipsoid form, andwherein the second ends of the tubes are joined at a second oppositepole of the spherical or ellipsoid form, each tube having a continuouschannel extending along at least a portion of its length.
 20. The methodof manufacturing of claim 19, further comprising positioning one or moreradioactive seeds, radioactive strands, radiopaque markers, and activeelements within one or more of the channels of at least a portion of theplurality of tubes.